REFLEX(R) EHS (ENDOSCOPIC HERNIA STAPLER)
FDA 510(k) clearance K933901 · decided 1993-11-19
Clearance details
- K-number
- K933901
- Device name
- REFLEX(R) EHS (ENDOSCOPIC HERNIA STAPLER)
- Applicant
- Richard-Allan Medical
- Decision
- Substantially Equivalent
- Date received
- 1993-08-10
- Decision date
- 1993-11-19
- Days to decision
- 101 days
- Clearance type
- Traditional
- Product code
- GAG
- Device class
- 2
- Regulation number
- 878.4740
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Richland, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.